European Union’s Chemicals Strategy for Sustainability
The European Union has one of the most comprehensive regulatory systems for chemicals risk management globally. Since its inception in 2007, EU authorities have registered over 21,000 substances under the EU’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) system, and over 200 substances have been classified as substances of very high concern, meaning that they can only be used in the EU under strict circumstances. Parallel to REACH, several thousand substances have been classified to better communicate their hazardous properties to consumers and professional users under the EU’s Classification Packaging and Labeling (CLP) system. The EU’s approach to chemicals risk management is often emulated (wholly or in part) by other economies around the world.
As a part of the EU’s Green Deal, the REACH and CLP Regulations, and the related Cosmetic Products Regulation are being revised based on the principles set out by the EU’s Chemicals Strategy for Sustainability. Ultimately, the objective of the upcoming changes is to protect human health and the environment and promote a general shift towards less polluting “safe and sustainable by design” chemistries. The revisions will make it easier for EU authorities to evaluate and restrict larger groups of chemicals that do not meet the EU’s standards for acceptable risk. Standards which are based on the precautionary principle (‘better safe than sorry!’) approach. While this approach is contrary to how the United States regulates risk, it is a principle set out in the EU’s foundational laws (“EU treaties”) and sets the tone for public policy across industries and sectors.
Accordingly, endocrine-disrupting, persistent, mobile, and bio-accumulative substances will all likely be banned following the revision of REACH and CLP. While there will be carve-outs for – yet to be defined - “essential use” chemistries, the shift towards an even more stringent regulatory approach will doubtless disrupt the European chemicals market, estimated to be worth approximately €500 billion in Europe annually. While legacy chemicals, coatings, cosmetics manufacturers will have to rise to the occasion and meet the challenges of the new regulatory environment, the shift towards more sustainable chemicals will open opportunities for market disruptors to win consumers’ confidence and gain market share in the EU.
The “safe and sustainable by design” (SSbD) concept is still under development – and will only be fully fleshed out over 2022 in the context of the revision of the REACH regulation. Nevertheless, the Chemicals Strategy for Sustainability provides insight into the EU Commission’s thinking on what criteria chemicals will have to fulfill to be considered safe and sustainable by design:
“At this stage, safe and sustainable-by-design can be defined as a pre-market approach to chemicals that focuses on providing a function (or service), while avoiding volumes and chemical properties that may be harmful to human health or the environment, in particular groups of chemicals likely to be (eco) toxic, persistent, bio-accumulative or mobile. Overall sustainability should be ensured by minimizing the environmental footprint of chemicals in particular on climate change, resource use, ecosystems and biodiversity from a lifecycle perspective.” (European Commission 2020).
Some of the technical details that will inform this process of setting the final definition – such as how to measure and set cut-off criteria for persistence and mobility of chemicals in the environment, or how to measure bioaccumulation of dangerous chemicals, are already being discussed in the context of the revision of the CLP Regulation. Other, more fundamental policy questions, however – such as what is meant by sustainability in this context – will be debated in the year(s) to come.
The initial suggestions for determining SSbD criteria will be set out by the Joint Research Centre (JRC), the European Union’s in-house research institution. According to current timelines, the JRC will present a paper to the Commission by the end of 2021. The JRC’s recommendations will feed into the Commission’s internal thinking on revising REACH. Interested parties will then be able to contribute their views on SSbD criteria (and all the other elements of the proposed REACH revision) during the REACH public consultation, which is expected to take place in the first quarter of 2022. The Commission has also announced that it will hold a workshop to seek the views of interested stakeholders on SSbD in March of 2022. There will also be additional opportunities to influence the legislative process as it passes through the European Parliament and the Council.
Process of developing SSbD criteria for EU REACH
• EU Chemicals Strategy for Sustainability sets out the revision of REACH (and CLP) - 2020 October
• Commission publishes roadmap on REACH review - 2021 May
• JRC Report to Commission with initial SSbD criteria - 2021 December
• Commission to launch public consultation on REACH review (including on SSbD) - Q1 2022 (indicative)
• Commission to publish legislative proposal on REACH revision - Q4 2022 (indicative)
• Start of EU legislative process between the European Parliament, the Council and the Commission - Q1 2023 (indicative)
The United States and Foreign Commercial Service team at the U.S. Mission to the EU stands ready to help U.S. companies (of all sizes) to engage with the EU’s process for overhauling its chemicals legislation. We can provide insights into the state of play of the regulatory process as well as into how you can have your opinion heard. Please don’t hesitate to get in touch with us.
Jim Curtis – Commercial Officer and Standards Attaché – jim.curtis@trade.gov
Peter Marton – Commercial Specialist – peter.marton@trade.gov
Additional Resources:
• AmCham EU’s position paper on the EU’s Chemicals Strategy for Sustainability.
• The European Commission’s Public Consultation page on CLP.
• The European Parliament’s legislative tracking page for the Chemicals Strategy for Sustainability.
• The European Chemical Industry Council’s page on the Chemicals Strategy for Sustainability.